JVT Advisors

Regulatory Affairs CMC Director

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Location: Cambridge, Massachusetts
Employment Type: Contract

Job Description

Contract Length:  1 year

Job Summary:  The Director, Regulatory Affairs CMC will act as a CMC regulatory representative to develop CMC regulatory strategies, submissions and compliance activities.

 

Responsibilities:

  • Provides strategic guidance on FDA and global CMC regulatory requirements for investigational and commercial products.
  • Compiles, reviews and approves CMC modules of development and marketing registration applications, amendments, and supplements for submission.
  • Develops and implements CMC regulatory strategies for the earliest possible product approval.
  • Assists with preparation and lead meetings with Health Authorities.
  • Manages and ensures compliance with all reporting requirements, including annual and periodic reports.
  • Serves as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.

Requirements:

  • 8+ years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 6 years in Chemistry, Manufacturing and Control (CMC) regulatory environment, Oncology experience preferred.
  • Small molecule and biologics knowledge is preferred.
  • Bachelor of Science in a scientific discipline (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred.
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • Regulatory experience supporting both development projects and marketed products.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.
  • Prior experience with NDA/BLA submission is strongly preferred.

 

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